Devices

FDA Clears Palliare Insufflation Expanded Use

FDA has cleared a Palliare 510(k) for the END-200 tubeset that expands the use of its EVA15 continuous pressure insufflation technology from laparoscopic surgery to endoscopic and endoluminal surgery. The EVA15 insufflator and smoke evacuation system is designed to create a safer operating room environment and deliver insufflation and smoke evacuation performance to meet the particular demands of laparoscopic, endoluminal, endoscopic, and robotic surgical procedures, the company says. The insufflator will allow therapeutic endoscopists to “benefit from insufflation technology that, up to now, has only been available to laparoscopic surgeons” it says. “For complex, long or high leak therapeutic endoscopy procedures, current insufflation requires careful ongoing management by the endoscopist. With this new technology, target insufflation pressure can be maintained automatically, raising it to a surgical standard of safety and efficiency, no longer requiring intervention from the endoscopist, allowing them to focus exclusively on their therapeutic procedure.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome